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DECAVAC® is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria. DECAVAC vaccine is approved for use in persons 7 years of age and older.
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DECAVAC vaccine, Tetanus and Diphtheria Toxoids Adsorbed, for intramuscular injection, is a sterile suspension of alum (aluminum potassium sulfate)-precipitated toxoids in an isotonic sodium chloride solution. The vaccine, after shaking, is a turbid liquid, whitish-gray in color.
Corynebacterium diphtheriae cultures are grown in a modified Mueller and Miller medium. (5) Clostridium tetani cultures are grown in a peptone-based medium containing an extract of bovine muscle tissue. The bovine muscle tissue used in this medium is US sourced. Tetanus and diphtheria toxins produced during the growth of the cultures are detoxified with formaldehyde. The detoxified materials are then separately purified by serial ammonium sulfate fractionation and diafiltration, and adsorbed onto alum.
Each 0.5 mL dose of DECAVAC vaccine is formulated to contain the following active ingredients: 5 Lf of tetanus toxoid and 2 Lf of diphtheria toxoid. The tetanus and diphtheria toxoids induce at least 2 units and 0.5 units of antitoxin per mL of serum, respectively, in the guinea pig potency test. Each 0.5 mL dose also contains a trace amount of thimerosal [mercury derivative, (≤0.3 mcg mercury/dose) not as a preservative] from the manufacturing process, aluminum potassium sulfate adjuvant (not more than 0.28 mg aluminum by assay), and not more than 100 mcg (0.02%) of residual formaldehyde.
The tip caps of the prefilled syringes may contain natural rubber latex. No other components of any presentation contain latex.